As part of an attempt to catch up with the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Health Canada, Australia’s Therapeutic Goods Administration (TGA) on Monday released five new consultations for public comment, including one that would forge new priority review and provisional approval pathways.
TGA’s priority review pathway, like Health Canada’s and FDA's pathway with the same name, will involve faster reviews of prescription drugs in certain circumstances, potentially allowing consumers with serious and life-threatening conditions to gain access to these medicines more quickly if an assessment results in a decision for registration.
Similarly, Australia’s provisional approval pathway, like FDA’s accelerated approval pathway and EMA’s conditional marketing authorization, will provide earlier access to certain promising new medicines that do not yet have a full dossier of clinical data but have solid early data on efficacy and safety (e.g. based on surrogate endpoints or other relevant data, rather than on patient safety and efficacy data from full Phase III clinical trials).
In opening the consultation on both pathways on Monday, TGA says it is looking for input on the proposed eligibility criteria and the proposed process for determining that a medicine meets the eligibility criteria for the pathways.
“While there are no standard criteria for expedited pathways used internationally that could be adopted by Australia, there are some common considerations,” TGA says, pointing to the seriousness of the disease or condition and its impact on people’s daily lives, the existence of currently effective interventions and whether the new medicine will provide a substantial benefit in some aspect of the patient outcomes.
The consultation on the two pathways follows an expert panel review in March 2015 that recommended ways to streamline the TGA’s registration processes and improve timely access to new medicines and medical devices.
The recommendations relating to expedited pathways arose from the observation that “Australia is out of step with international regulators,” such as FDA, EMA and Health Canada, which all have the capacity to expedite assessment of prescription medicines in certain circumstances.
“The panel concluded that allowing for greater flexibility in assessment pathways for medicines and medical devices (including greater use of overseas assessment reports and granting provisional registration in certain circumstances) would expedite access to market without compromising the safety, quality and efficacy or performance of medicines and medical devices,” TGA says.
How it Will Work
With a view to reducing the time to a decision regarding registration of a medicine in Australia to 150 working days, TGA says it believes its new priority review pathway will be consistent with the benchmarks set by FDA and EMA.
As for logistics, sponsors will submit an application form seeking designation for one of the pathways and provide a rationale as to why the medicine meets the eligibility criteria.
Similar to the EMA process, TGA suggests that an application will be submitted to it approximately 10-12 weeks prior to submission of the dossier for the registration process.
“One of the proposed principles for our expedited pathways is that sponsors will be responsible for providing all information necessary to receive and maintain the designation. For the Priority Review pathway, sponsors will need to provide evidence of Good Manufacturing Practice (GMP) compliance or show that they have applied to obtain the necessary GMP certificate or GMP clearance,” the consultation says.
Pre-submission meetings will be recommended for sponsors intending to apply for designation to an expedited pathway, and such meetings will occur six to seven months prior to submission of the dossier for the registration process.
TGA’s principal medical advisor will assess the information provided by the sponsor against the relevant criteria to determine whether a medicine should be granted a designation for the priority review or provisional approval pathway and will have about 20 working days from acceptance and acknowledgement to the sponsor of a complete application to make the designation decision.
As far as paying for the expedited reviews, TGA proposes a new fee associated with the designation process to apply to all applications and reflect the TGA resources required for this new designation process. The proposed fee for the designation process for the expedited pathways, and any other changes to the fees and charges that may apply to the registration of these medicines, will be determined in TGA’s annual review of fees and charges in consultation with industry.
Comments on the consultation have to be submitted by 12 December.
In addition to the two new approval pathways, TGA also opened consultations on enhanced international collaboration in the regulation of prescription medicines.
TGA is looking to adopt a two-step process to identify suitable opportunities for further collaboration with comparable overseas regulators, as well as a process for how to identify such regulators.
TGA is also consulting on an EU guideline on risk management of advanced therapies, as well as guidance on biovigilance responsibilities of sponsors of biologics and guidance on risk management plans for medicines and biologicals.
Comments on these consultations must be submitted by 16 December.
A log of future consultations can be found at: Implementation of reforms - public consultation forecast.